Clearance Summary
HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE received FDA 510(k) clearance under submission number K811011, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1981-05-15.
- Submission: K811011
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.7675
- Decision date: 1981-05-15
Classification & Regulation
This clearance is catalogued under FDA product code GIA and 21 CFR 864.7675, within the Hematology review panel as a Class I device.